Jetrea

Vitreomacular Adhesion

Treatment of symptomatic vitreomacular adhesion (VMA).1 2 14

Provides pharmacologic (nonsurgical) option for patients with less severe symptomatic VMA to receive treatment at an earlier stage and potentially avoid surgical complications.2 3 9 10 11 14 5

Storage

Parenteral

Frozen at or below -20°C.1 Protect from light.1 Store in original package until use.1

Ocriplasmin injection is used to treat symptomatic vitreomacular adhesion. Symptomatic vitreomacular adhesion is an eye condition related to aging that may lead to blurring of vision or blindness.

This medicine is only administered by or under the supervision of your doctor.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ocriplasmin injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ocriplasmin injection in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Detached retina (eye disorder) or
• Dyschromatopsia (color vision disorder) or
• Eye infection or
• Glaucoma (increased pressure in the eye) or
• Lens subluxation (partial dislocation of the eye lens)—Use with caution. May make these conditions worse.

Your eye doctor will want to check your progress at regular visits, especially during the first few days after you receive this medicine.

Serious eye problems may occur with this medicine. Check with your eye doctor right away if your eye becomes red, sensitive to light, or painful, or if you have a change in vision, or feel increased pressure in the eye several days after the injection.

This medicine may cause temporary blurred vision. Avoid driving, using machines, or doing anything else that could be dangerous if you are not able to see well. If this symptom persists, have your eyes checked by an eye doctor.

None

Pregnancy

Teratogenic Effects

Pregnancy Category C. Animal reproduction studies have not been conducted with ocriplasmin. There are no adequate and well-controlled studies of ocriplasmin in pregnant women. It is not known whether ocriplasmin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The systemic exposure to ocriplasmin is expected to be low after intravitreal injection of a single 0.125 mg dose. Assuming 100% systemic absorption (and a plasma volume of 2700 mL), the estimated plasma concentration is 46 ng/mL. Jetrea should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether ocriplasmin is excreted in human milk. Because many drugs are excreted in human milk, and because the potential for absorption and harm to infant growth and development exists, caution should be exercised when Jetrea is administered to a nursing woman.

Pediatric Use

The use of Jetrea in pediatric patients is not recommended. A single center, randomized, placebo controlled, double masked clinical study to investigate the safety and efficacy of a single intravitreal injection of 0.175 mg ocriplasmin in pediatric subjects as an adjunct to vitrectomy was conducted in 24 eyes of 22 patients. There were no statistical or clinical differences between groups for the induction of total macular posterior vitreous detachment (PVD), any of the secondary endpoints or adverse events.

Geriatric Use

In the clinical studies, 384 and 145 patients were ≥ 65 years and of these 192 and 73 patients were ≥ 75 years in the Jetrea and vehicle groups respectively. No significant differences in efficacy or safety were seen with increasing age in these studies.

The efficacy and safety of Jetrea was demonstrated in two multicenter, randomized, double masked, vehicle-controlled, 6 month studies in patients with symptomatic vitreomacular adhesion (VMA). A total of 652 patients (Jetrea 464, vehicle 188) were randomized in these 2 studies. Randomization was 2:1 (Jetrea:vehicle) in Study 1 and 3:1 in Study 2.

Patients were treated with a single injection of Jetrea or vehicle. In both of the studies, the proportion of patients who achieved VMA resolution at Day 28 (i.e., achieved success on the primary endpoint) was significantly higher in the ocriplasmin group compared with the vehicle group through Month 6 (Table 2 and Figure 5).

Table 2: Proportion of Patients with VMA Resolution in the Study Eye (Study 1, Study 2: Full Analysis Set)

Figure 5: Proportion of Patients with VMA Resolution in the Study Eye (Study 1 and Study 2)

Total posterior vitreous detachment (PVD) induction in symptomatic vitreomacular adhesion patients was evaluated by B-scan ultrasound. A statistically significantly higher percentage of Jetrea treated patients achieved total PVD at Day 28 compared to vehicle treated patients in Study 1 (16% vs. 6%; p=0.014) and in Study 2 (11% vs. 0%; p<0.01).

The number of patients with at least 3 lines increase in visual acuity was numerically higher in the ocriplasmin group compared to vehicle in both trials, however, the number of patients with at least a 3 lines decrease in visual acuity was also higher in the ocriplasmin group in one of the studies (Table 3 and Figure 6).

Table 3: Categorical Change from Baseline in BCVA at Month 6, Irrespective of Vitrectomy (Study 1 and Study 2)

Figure 6: Percentage of Patients with Gain or Loss of ≥ 3 Lines of BCVA at Protocol-Specified Visits

In the days following Jetrea administration, patients are at risk of developing intraocular inflammation/infection. Advise patients to seek immediate care from an ophthalmologist if the eye becomes red, sensitive to light, painful, or develops a change in vision [see Warnings and Precautions (5.2)].

Patients may experience temporary visual impairment after receiving an intravitreal injection of Jetrea [see Warnings and Precautions (5.1)]. Advise patients to not drive or operate heavy machinery until this visual impairment has resolved. If visual impairment persists or decreases further, advise patients to seek care from an ophthalmologist.

Manufactured by:

ThromboGenics, Inc.

101 Wood Avenue South, Suite 610

Iselin, NJ 08830

U.S. License Number: 1866

©2012, ThromboGenics, Inc. All rights reserved.

Revised February 2017

Initial U.S. Approval: 2012

ThromboGenics U.S. patents: 7,445,775; 7,547,435; 7,914,783 and other pending patents.

Package Label - Principal Display Panel - Jetrea - Vial 1.25 mg

Package Label - Principal Display Panel - Jetrea - Carton 1.25 mg

Applies to ocriplasmin ophthalmic: intraocular solution

Along with its needed effects, ocriplasmin ophthalmic (the active ingredient contained in Jetrea) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking ocriplasmin ophthalmic:

• Bloody eyes
• blurred vision or other change in vision
• decreased vision
• eye pain
• redness of the eye
• seeing flashes or sparks of light
• sensitivity of the eye to light
• tearing

• Change in color vision
• difficulty seeing at night
• eye discomfort
• loss of vision
• seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
• throbbing pain

Some side effects of ocriplasmin ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Dry eyes